MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; CATHETER,INTRAVASCULAR,THE

Catalog Number 4251628-03

Device Problem Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report number (b)(4).1 used sample was returned for evaluation.The sample included the needle and the needle hub, but the catheter hub was not returned.The returned needle was examined under a smartscope and no dents or abnormalities were observed on the needle surface.The needle's outer diameter and degree of slanting were measured and both were within specification.The safety clip was visually examined and no damage or deformation was observed.In order to test the functionality of the safety clip, the returned sample was assembled into a retain sample catheter hub and then the needle was withdrawn.The safety clip engaged as intended.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned sample met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by user facility (translation of user facility information by bbm sales organization in (b)(6)): the passive safety shield did not automatically activate when the needle tip passed through the hub, resulting in a needlestick.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 10233653
• MDR Text Key: 197920822
• Report Number: 9610825-2020-00133
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4251628-03
• Device Lot Number: 20C06G8315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1